Multi-component Intervention for Diabetes in Adults With Serious Mental Illness

Serious mental illnesses (SMI), including schizophrenia, bipolar disorder, and
schizoaffective disorder, are associated with increased medical comorbidity and premature
mortality from diabetes and cardiovascular disease. Unhealthy lifestyles, including
energy-dense (obesogenic) diet, sedentary behavior, and cigarette smoking are important risk
factors for diabetes and accelerated biological aging. All of these risk factors are
potentially modifiable. There is considerable literature documenting the effectiveness of
strategies to prevent and manage diabetes in the general population; yet, these interventions
are rarely offered to people with SMI. Residential Care Facilities (RCFs), called
Board-and-Care Homes in California, are a common housing modality for patients with SMI; they
provide a venue that can maximize efficiency and sustainability of a lifestyle intervention.
The goals of the proposed four-year study are to tailor a multi-component intervention to
this high-risk group. The study will be a hybrid effectiveness-implementation (Hybrid Type 1)
trial of a Multi-component Intervention for Diabetes risk reduction in Adults with SMI
(MIDAS) in licensed RCFs in San Diego county. As a Hybrid Type 1 study, the primary emphasis
will be on determining the effectiveness of the intervention to achieve desired health
outcomes while also systematically collecting data on its implementation within RCFs that
will inform implementation strategy refinement. Main components of MIDAS include: (1)
Education about diabetes and lifestyle, (2) Dietary intervention at the facility and resident
level, (3) Increased physical activity, and (4) Smoking cessation / reduction. The
investigators will employ a modified cluster-randomized stepped wedge and adaptive trial
design involving 210 residents with SMI and 120 staff members from 12 RCFs. The RCFs will be
divided randomly into four cohorts of three RCFs each. Each cohort will be tested over a
15-month period that includes three phases: a three-month initial control phase (no
intervention, from baseline month 0 to end of month 3), a six-month intervention phase
(months 4 through 9), and a six-month follow-up phase (no intervention, months 10 through
15). All the study participants will be assessed quarterly during the 15-month period. Our
investigators will train RCF staff (especially the Activity Director and cook) to increase
physical activity and reduce smoking, and to implement healthful dietary modifications among
the residents, using evidence-based interventions. During the intervention phase, the RCF
Activity Director will conduct twice-weekly manualized group sessions on education about
diabetes, nutrition, exercise, and smoking cessation/reduction, to deliver a multi-component
group intervention. We will also explore if there are improvements in blood-based research
biomarkers of insulin resistance and inflammation in the RCF residents with SMI. This project
is responsive to RFA-MH-17-608, and related to NIMH Strategic Objective #3.3B: testing
interventions for effectiveness in community practice settings. If successful, MIDAS will be
sustained and disseminated, and would lead to reduction in excess medical comorbidity and
mortality associated with SMI.

Participants: A total of 12 RCFs (30 to 45 beds each), 210 resident participants, and 120
staff members (1 manager, 2 activity directors, 1 cook, and 6 other staff members per
facility) will be enrolled.

Inclusion and Exclusion Criteria:

Residential Care Facilities (RCFs):

Inclusion Criteria:

1. Licensed by California Division of Social Services' Community Care Licensing

2. Serves only individuals with SMI

3. Has >15 residents currently living in the facility

4. Willing to participate

Staff Participants:

Inclusion Criteria:

1. Age >21 years

2. Fluent in English

3. Written informed consent to participate

Exclusion Criteria:

(1) Plans to leave the RCF during the next year.

Resident Participants:

Inclusion Criteria:

1. Age 18 - 65 years

2. Chart diagnosis of an SMI, mainly schizophrenia, schizoaffective disorder, or bipolar
disorder

3. Current treatment with antipsychotics

4. Fluent in English

5. Written informed consent to participate in this study

Exclusion Criteria:

1. Chart diagnosis of dementia or intellectual disability disorder

2. Active substance abuse (non-tobacco)

3. Medical problems that interfere with ability to complete assessments and intervention